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Draft “DMF” Regulation in China Draws International Pharma Attention

Nov 12th, 2011

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The filing requirements China is proposing for active pharmaceutical ingredients (APIs) and pharmaceutical “auxiliary materials” – including their mandatory nature and the lack of clarity regarding how changes to the filings will be handled – are areas of concern in international pharma’s assessment of the country’s evolving CMC program.

A draft regulation on “Filing of APIs and Pharmaceutical Auxiliary Materials” was released for public comment by China’s State Food and Drug Administration (SFDA) in the fall of 2010.  A second public consultation on the new reg is expected to begin soon as a result of the extensive comments submitted on the draft, including those by the R&D-based Pharmaceutical Association Committee (RDPAC), which represents international companies in China.

The concerns on the draft regulation received attention at sessions focused on the evolving CMC and GMP efforts in China at the AAPS annual meeting in Washington, DC, in late October, and at the ISPE annual meeting in Dallas, Texas, in early November.

[The story continues for subscribers on page 2.  Non-subscribers can purchase the story for $95 — or the series of four recent IPQ stories on China for $295 — by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

Also see the following recent related stories:

China’s SFDA Begins Inspections of Overseas Manufacturers

Current Review Policies and Staffing Levels at China’s SFDA at Odds with its ICH Q8-10 Objectives

China’s Efforts to Harmonize with International CMC Regulatory Norms Provides Opportunities for Industry Input

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